510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133973Substantially Equivalent

Tempus Pro with Enhanced Features

Remote Diagnostic Technologies Ltd., Basingstoke, GB / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133973 is the FDA 510(k) clearance record for TEMPUS PRO WITH ENHANCED FEATURES, a class II device, cleared for Remote Diagnostic Technologies , Ltd. on under FDA product code QYW (Hospital Cardiac Telemetry). FDA's definition for product code QYW reads: "Devices are intended to continuously record, display, and/or analyze electrocardiograms of patients in in a healthcare facility for detecting conditions that may require prompt intervention. They may include automatic detection and...". FDA records list 12 510(k) clearances for Remote Diagnostic Technologies , Ltd., from to . As of , FDA records show no recalls naming K133973.

Clearance record

Decision date
Received
(231 days to decision)
Product code
QYW Hospital Cardiac Telemetry
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Remote Diagnostic Technologies , Ltd. The Old Coach House, The Ave., Farleigh Wallop, Basingstoke, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QYW

Trailing 12 months

FDA records hold no clearances under product code QYW in the trailing twelve months.

FDA records show no clearances under product code QYW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QYW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260